Is Direct Communication With FDA More Effective Than Formal Dispute Resolution

Several years ago, FDA announced that drug firms that disagreed with its decisions could file a formal dispute resolution (FDR) and request to have the Agency's decision reviewed.  The prospect was so attractive that about two companies took the Agency up on this offer over the next few years.  We surveyed companies at the time and their consensus was "we'd never do it. It's not worth the effort." However, Eye on FDA notes that a number of companies are now formally filing FDR's. They're filing these FDR's for nonapproval letters, rather than plant inspections, but Mark Senak reaches the same conclusion about FDR's that our survey respondents did: non vale la pena.  What does help is proactive communication with the Agency. More from Eye on FDA. -AMS